Lasik vision correction surgery has been performed in the United States for almost ten years. It has become a massive business with specialized centers opening in most markets and advertising freedom from glasses. However, not everyone’s a good candidate and some suffer life-changing side effects — lost vision, dry eye, night-vision problems.
Today, the Food and Drug Administration is beginning a major new effort to see if warnings about the risks are strong enough. The FDA estimates that approximately 5 percent of patients are dissatisfied, but be more specific due to the lack of data. The FDA is now working with eye surgeons in a major study expected to enroll hundreds of Lasik patients to try to better understand who has bad outcomes and exactly what their complaints are.
About 7.6 million Americans have undergone some form of laser vision correction, including the Lasik procedure. In performing the Lasik procedure, doctors cut a flap in the cornea — the clear covering of the eye— aim a laser underneath it and zap to reshape the cornea for sharper sight.
The vast majority, 95 percent, of patients see more clearly after Lasik. However, some patients have severe complications that leave poor vision. Other side effects, such as dry eye can range from an annoyance to so severe that people suffer intense pain and need surgery to retain what little moisture their eyes form.
Dry eye is common even among people who never have eye surgery, and increases as people age. Solomon says 31 percent of Lasik patients have some degree of it before the surgery, and that about 5 percent worsen afterwards.
The FDA has long known of those side effects, and thus for years has a Web site with warnings for Lasik patients and required that doctors give every potential patient a brochure outlining risks..
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